Medical instrument with a shutter for sealing a test strip port

ABSTRACT

A medical instrument ( 300, 700, 1300, 1400, 1500, 1600 ) for performing a measurement ( 1513 ) on a biological sample using a test strip ( 310 ), wherein the medical instrument comprises: a housing ( 302 ) and an analytical unit ( 1508 ) for analyzing the test strip, wherein the analytical unit is within an interior volume ( 308 ). The analytical unit comprises a test strip mount ( 1510 ) configured for receiving the test strip to perform the measurement. The instrument further comprises a test strip port ( 312 ) between an exterior surface ( 304 ) and an interior surface ( 306 ). The test strip port is aligned with the test strip mount along an insertion direction ( 328 ). The medical instrument further comprises a shutter ( 100 ) for sealing the test port. The shutter is configured for being in a open position and a closed position. The shutter is within the interior volume. The shutter is configured for sealing the test port when in the closed position. The shutter comprises a test strip opening ( 106 ). The test strip opening is aligned with the test strip port and the test strip mount when the shutter is in the open position. The shutter has a first sealing surface ( 118 ). The test strip port has a second sealing surface ( 120 ). The first sealing surface and the second sealing surface are configured to mate in the closed position. The shutter comprises a mechanism for moving the shutter between the open position and the closed position. Moving the shutter between the closed position and the open position comprises a rotation of the shutter parallel to the insertion direction. The medical instrument further comprises an actuator ( 2506 ) for actuating the mechanism to move the shutter between the open position and the closed position.

FIELD OF THE INVENTION

The invention relates to medical instruments and methods of operatingmedical instruments, in particular to the cleaning and disinfection oftest strip ports of analyzers

BACKGROUND AND RELATED ART

In hospitals and other clinical settings, healthcare providers may usemedical instruments such as test strip readers or analyte monitoringdevices to perform diagnostic tests on multiple patients. Currentinfection control protocols require that the healthcare provider cleanthe medical instrument between each use or between each patient. Thiscan mean that a particular medical instrument may cleaned thousands oftimes within the course of a year. It is even possible that a medicalinstrument may be cleaned tens of thousands of times within its servicelife.

A typical cleaning and disinfection protocol may require a number ofsteps. For example the healthcare provider may first clean the medicalinstrument to remove visible contaminates from its exterior surface.Next the medical instrument may be disinfected using a disinfectingliquid or a textile impregnated with the disinfecting liquid. After thisthe medical instrument is allowed to dry.

A challenge in cleaning such medical instruments is that fluids used forthe cleaning and/or disinfecting steps can destroy electronic componentsor delicate instruments used for performing the diagnostic tests if suchfluids enter into the interior volume of the medical instrument, e.g.via the test element port. Ports used to insert biological samples ortest elements or test strips not only need to be sealed against thesefluids, but they also need to be able to be reliably sealed for tens ofthousands of cycles.

United States patent application US 2012/0150448 A1 discloses a handheld analyte measurement system with a test strip port.

U.S. Pat. No. 8,158,081 B2 discloses an analyte monitoring device with acover for covering an opening in the analyte meter. The cover is on theexterior of the analyte meter.

The document. ACCU-CHEK Inform II BLOOD GLUCOSE MONITORING SYSTEMOperator's Manual, version 3.0. (Roche Diagnostics GmbH, Mannheim,Germany, March 2013; available online athttp://www.accu-chekinformii.com/pdf/05234646002_ACl2_OpsMan.pdf)describes a cleaning method for a handheld blood glucose monitoringsystem on page 124 to 131.

European Patent application publication EP 2741076 A1 pertains to abiological sample measurement device, which is intended to be easier touse. To achieve this object, the present invention comprises a main bodycase having a sensor insertion opening into which a sensor for measuringbiological samples is inserted, a connection terminal provided withinthe main body case behind the sensor insertion opening, and a shutterthat is provided within the main body case between the sensor insertionopening and the connection terminal and that opens and closes the sensorinsertion opening.

PCT patent application publication WO 2010/024971 A1 discloses a devicefor preventing electrical shock from a device with electricalinterfaces. A shutter or other barrier associated with the device thatphysically prevents access or contact to one of the electricalinterfaces while another electrical interface is in use.

United States Patent application publication US 2010/0249567 (hereafter“the '567 application”) discloses a portable blood sugar measuringdevice comprising a tape unit for winding a test tape forward insections, a detection unit for detecting measured values on the sectionsof tape to which body fluid has been applied, and a housing to hold thetape unit and detection unit. The tape unit and/or the detection unitcan be deflected relative to the housing from an operating positionagainst a flexible restoring element when subjected to a shock load.Also disclosed is a novel cover having open and closed positions. Thecover is positioned at an opening of the housing through which thereceiving site of the tape unit protrudes. The cover thus protects thereceiving site from external effects when the cover is in the closedposition. Similarly, the receiving site is accessible to apply bodyfluid thereto when the cover is in the open position.

SUMMARY

The invention provides for a method of operating a medical instrumentand a medical instrument in the independent claims. Embodiments aregiven in the dependent claims.

As will be appreciated by one skilled in the art, aspects of the presentinvention may be embodied as an apparatus, method or computer programproduct. Accordingly, aspects of the present invention may take the formof an entirely hardware embodiment, an entirely software embodiment(including firmware, resident software, micro-code, etc.) or anembodiment combining software and hardware aspects that may allgenerally be referred to herein as a “circuit,” “module” or “system.”Furthermore, aspects of the present invention may take the form of acomputer program product embodied in one or more computer readablemedium(s) having computer executable code embodied thereon.

Any combination of one or more computer readable medium(s) may beutilized. The computer readable medium may be a computer readable signalmedium or a computer readable storage medium. A ‘computer-readablestorage medium’ as used herein encompasses any tangible storage mediumwhich may store instructions which are executable by a processor of acomputing device. The computer-readable storage medium may be referredto as a computer-readable non-transitory storage medium. Thecomputer-readable storage medium may also be referred to as a tangiblecomputer readable medium. In some embodiments, a computer-readablestorage medium may also be able to store data which is able to beaccessed by the processor of the computing device. Examples ofcomputer-readable storage media include, but are not limited to: afloppy disk, a magnetic hard disk drive, a solid state hard disk, flashmemory, a USB thumb drive, Random Access Memory (RAM), Read Only Memory(ROM), an optical disk, a magneto-optical disk, and the register file ofthe processor. Examples of optical disks include Compact Disks (CD) andDigital Versatile Disks (DVD), for example CD-ROM, CD-RW, CD-R, DVD-ROM,DVD-RW, or DVD-R disks. The term computer readable-storage medium alsorefers to various types of recording media capable of being accessed bythe computer device via a network or communication link. For example adata may be retrieved over a modem, over the internet, or over a localarea network. Computer executable code embodied on a computer readablemedium may be transmitted using any appropriate medium, including butnot limited to wireless, wire line, optical fiber cable, RF, etc., orany suitable combination of the foregoing.

A computer readable signal medium may include a propagated data signalwith computer executable code embodied therein, for example, in basebandor as part of a carrier wave. Such a propagated signal may take any of avariety of forms, including, but not limited to, electro-magnetic,optical, or any suitable combination thereof. A computer readable signalmedium may be any computer readable medium that is not a computerreadable storage medium and that can communicate, propagate, ortransport a program for use by or in connection with an instructionexecution system, apparatus, or device.

‘Computer memory’ or ‘memory’ is an example of a computer-readablestorage medium. Computer memory is any memory which is directlyaccessible to a processor. ‘Computer storage’ or ‘storage’ is a furtherexample of a computer-readable storage medium. Computer storage is anynon-volatile computer-readable storage medium. In some embodimentscomputer storage may also be computer memory or vice versa.

A ‘processor’ as used herein encompasses an electronic component whichis able to execute a program or machine executable instruction orcomputer executable code. References to the computing device comprising“a processor” should be interpreted as possibly containing more than oneprocessor or processing core. The processor may for instance be amulti-core processor. A processor may also refer to a collection ofprocessors within a single computer system or distributed amongstmultiple computer systems. The term computing device should also beinterpreted to possibly refer to a collection or network of computingdevices each comprising a processor or processors. The computerexecutable code may be executed by multiple processors that may bewithin the same computing device or which may even be distributed acrossmultiple computing devices.

Computer executable code may comprise machine executable instructions ora program which causes a processor to perform an aspect of the presentinvention. Computer executable code for carrying out operations foraspects of the present invention may be written in any combination ofone or more programming languages, including an object orientedprogramming language such as Java, Smalltalk, C++ or the like andconventional procedural programming languages, such as the “C”programming language or similar programming languages and compiled intomachine executable instructions. In some instances the computerexecutable code may be in the form of a high level language or in apre-compiled form and be used in conjunction with an interpreter whichgenerates the machine executable instructions on the fly.

The computer executable code may execute entirely on the user'scomputer, partly on the user's computer, as a stand-alone softwarepackage, partly on the user's computer and partly on a remote computeror entirely on the remote computer or server. In the latter scenario,the remote computer may be connected to the user's computer through anytype of network, including a local area network (LAN) or a wide areanetwork (WAN), or the connection may be made to an external computer(for example, through the Internet using an Internet Service Provider).

Aspects of the present invention are described with reference toflowchart illustrations and/or block diagrams of methods, apparatus(systems) and computer program products according to embodiments of theinvention. It will be understood that each block or a portion of theblocks of the flowchart, illustrations, and/or block diagrams, can beimplemented by computer program instructions in form of computerexecutable code when applicable. It is further under stood that, whennot mutually exclusive, combinations of blocks in different flowcharts,illustrations, and/or block diagrams may be combined. These computerprogram instructions may be provided to a processor of a general purposecomputer, special purpose computer, or other programmable dataprocessing apparatus to produce a machine, such that the instructions,which execute via the processor of the computer or other programmabledata processing apparatus, create means for implementing thefunctions/acts specified in the flowchart and/or block diagram block orblocks.

These computer program instructions may also be stored in a computerreadable medium that can direct a computer, other programmable dataprocessing apparatus, or other devices to function in a particularmanner, such that the instructions stored in the computer readablemedium produce an article of manufacture including instructions whichimplement the function/act specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer,other programmable data processing apparatus, or other devices to causea series of operational steps to be performed on the computer, otherprogrammable apparatus or other devices to produce a computerimplemented process such that the instructions which execute on thecomputer or other programmable apparatus provide processes forimplementing the functions/acts specified in the flowchart and/or blockdiagram block or blocks.

The invention provides for a method of operating the medical instrumentand a medical instrument in the independent claims. Embodiments aregiven in the dependent claims.

In one aspect the invention provides for a method of operating a medicalinstrument. The medical instrument is an analyzer for performing ameasurement on a biological sample using a test strip. The analyzercould for example be a handheld analyzer or a table top analyzer.

A biological sample as used herein encompasses also any chemical productderived, copied, replicated, or reproduced from a sample taken from anorganism.

A test strip as used herein encompasses a ribbon-shaped substrate forreceiving a liquid biological sample. A test strip is a disposableelement containing chemicals that react with the analyte to bedetermined in the biological sample and is used for a singlemeasurement. The determination of the analyte can be performed usingdifferent technologies, e.g. optical or electrochemical methods, andtherefore the test strip comprises specific measurement structures toperform these measurements, e.g. optical test fields or electrodestructures.

The medical instrument comprises a housing with an exterior surface. Thehousing comprises an interior surface surrounding an interior volume. Inother words an analytical unit is inside of the housing of the medicalinstrument.

The medical instrument further comprises an analytical unit foranalyzing the test strip. The analytical unit is within the interiorvolume. The analytical unit comprises a test strip mount configured forreceiving the test strip to perform the measurement. The medicalinstrument further comprises a test strip port between the exteriorsurface and the interior surface. The test strip port is configured forreceiving the test strip. The test strip port is aligned with the teststrip mount along an insertion direction. The medical instrument furthercomprises a shutter for sealing the test port. The shutter is configuredfor being in an open position and a closed position. The shutter iswithin the interior volume. The shutter is configured for sealing thetest port when in the closed position. The shutter comprises a teststrip opening. The test strip opening is aligned with the test stripport and the test strip mount when the shutter is in the open position.

The shutter has a first sealing surface. The test strip port has asecond sealing surface. The first sealing surface and the second sealingsurface are configured to mate in the closed position. The shuttercomprises a mechanism for moving the shutter between the open positionand the closed position. Moving the shutter between the closed positionand the open position comprises a rotation of the shutter parallel tothe insertion direction. In other words the shutter is operable forbeing rotated between the closed and the open position.

The medical instrument further comprises an actuator for actuating themechanism to move the shutter between the open position and the closedposition. The actuator for instance may be a motor or other device whichmay be controlled by a processor for controlling the medical instrumentfor opening and closing the shutter. In other embodiments there may be amechanism which is actuated by hand. For example a lever or other devicemight be used for actuating the mechanism.

The method comprises the step of controlling the actuator to actuate themechanism to move the shutter into the open position. The method startsby the shutter being in the open position. Next a biological sample isplaced onto a test strip. The next step in the method is to insert thetest strip into the test strip port such that the test strip passesthrough the test strip support and into the test strip mount. The stepsof placing the sample onto the test strip and inserting the test stripinto the test strip port can also be performed in reverse order, inparticular if the test strip comprises sample transport structures (e.g.a capillary channel) which can transport the biological sample from asample application port of the test strip which is located outside ofthe medical instrument if the test strip is inserted into the test stripport to the measurement structures of the test strip which are locatedinside of the medical instrument if the test strip is inserted into thetest strip port. The test strip is now in a position where themeasurement of the biological sample can be performed by the analyticalunit. The method further comprises analyzing the test strip with theanalytical unit to perform the measurement.

Next the method comprises removing the test strip from the medicalinstrument. The next step in the method is to control the actuator toactuate the mechanism to move the shutter into the closed position. Thetest strip port is now sealed by mating the first sealing surface andthe second sealing surface. The method further comprises cleaning theexterior surface of the medical instrument. Cleaning may includecleaning and/or disinfecting.

This embodiment may have the benefit of providing for a medicalinstrument which can be more readily cleaned. This for instance may bebeneficial for test strip analyzers that are used in a clinicalsituation in a doctor's office or a hospital. In such situations themedical instrument should be cleaned after every use to ensure properhygiene and reduce the chances that an infection is spread. Having theshutter within the interior volume makes it easier to clean the medicalinstrument.

In clinical use, healthcare professionals are typically required tofollow a cleaning protocol when using a medical instrument more thanonce. An typical cleaning protocol usually requires the health careprofessional to clean the outer surface of the medical instrument toensure that there is no organic material or other containments visible.After this step the medical professional will usually clean the surfacewith a liquid disinfectant to further clean the surface and kill ordeactivate any microorganism such as bacteria or viruses. The liquiddisinfectant could for example be provided in the form of a wipe ortowel that is infused or saturated with the liquid disinfectant. Afterthis cleaning, the health care professional allows the surface to dryand/or wipes it clean. Medical instruments used in clinics or hospitalsmay be used repeatedly during the day and are cleaned according to sucha protocol after each use. This may result the medical instrument beingcleaned thousands of times during the lifetime of its usage. The methodand medical instrument may provide for a medical instrument that may bemore easily cleaned and/or able to better survive repeated cleaningsand/or sterilizations.

In the '567 application, there are two shutters 48 which are half-shellshaped and which rotate about the pivot 50. In par. [0039] it isdisclosed that the shutters are able to screen the receiving site 44from contamination. However, in FIG. 3 of D3 it is clear that theshutters are circular. It is not disclosed if these shutters are sealedor not where the shutters 48 contacts the housing 10. It is likely thatthe shutters would not be able to form a reliable seal with the housingto prevent fluid from entering the device of D3 during the performanceof repeated cleaning protocols.

In the '567 application, the shutters 48 close the opening 42 with twohalf-shell flaps. If the shutters of the device of the '567 applicationare closed, such as is illustrated in FIG. 5, the outer surface of theshutters 48 will be exposed when the device is cleaned. The point wherethe two shutters touch to close off the opening 42 is not within aninterior volume of the device.

In contrast, in the present embodiment the shutter is within theinterior volume. This may have the benefit of reducing the area of theshutter exposed during cleaning of the medical instrument.

In the '567 application there are two shutters 48 that are rotated intoposition. In contrast in the present embodiment there is only oneshutter. The present embodiment may have the advantage that there arefewer moving parts.

In the '567 application the two shutters 48 are rotated perpendicular tothe direction in which the receiving head 40 extends through the opening10. The mechanism of the '567 application would be unsuitable for a teststrip. The mechanism in the '567 application is for closing off a largereceiving head and is not suitable for closing an opening for a teststrip.

In another embodiment, the second sealing surface is within the interiorvolume.

In another embodiment, the second sealing surface is on the on theinterior surface.

In another embodiment, in the open position the first sealing surface iswithin the interior volume.

In another embodiment, the first sealing surface and the second sealingsurface form the seal within the interior volume when the shutter is inthe closed position. This may have the advantage of minimizing thesurface area of the

In another embodiment, the test strip port is an opening in the housing.

In another embodiment, the test strip port contacts the interior surfaceand the exterior surface.

In another embodiment, the test strip opening is a hole within theshutter. Having the test strip opening as a hole within the shutter mayhave the advantage that the test strip opening is kept clean when theshutter is closed and when the medical instrument is cleaned cleaningagent would not be able to come into contact with the test stripopening.

In another embodiment, the test strip opening is a test strip support.

In another aspect the invention provides for a medical instrument. Themedical instrument is an analyzer for performing a measurement on abiological sample using a test strip. The medical instrument comprises ahousing with an exterior surface. The housing comprises an interiorsurface surrounding the interior volume. The medical instrument furthercomprises an analytical unit for analyzing the test strip. Theanalytical unit is within the interior volume. The analytical unitcomprises a test strip mount configured for receiving the test strip toperform the measurement. The medical instrument further comprises a teststrip port between the exterior surface and the interior surface.

The test strip port is configured for receiving the test strip. The teststrip port is aligned with the test strip mount along an insertiondirection. The medical instrument further comprises a shutter forsealing the test port. The shutter is configured for being in an openposition and a closed position. The shutter is within the interiorvolume. The shutter is configured for sealing the test port when in theclosed position. The shutter comprises a test strip opening. The teststrip opening is aligned with the test strip port and the test stripmount when the shutter is in the open position. The shutter has a firstsealing surface.

The test strip port has a second sealing surface. The first sealingsurface and the second sealing surface are configured to mate in theclosed position. By mating, that means that the first sealing surfaceand the second sealing surface seal the test strip port. The shuttercomprises a mechanism for moving the shutter between the open positionand the closed position. Moving the shutter between the closed positionand the open position comprises a rotation of the shutter parallel tothe insertion direction. The medical instrument further comprises anactuator for actuating the mechanism to move the shutter between theopen position and the closed position.

In some examples the test strip opening may be a hole or opening in theshutter. In other examples the test strip opening may be a region thatis cut away from the shutter. So in some examples the test strip openingis a hole in the shutter. In other examples the test strip opening maybe formed by an edge of the shutter.

In another embodiment the medical instrument is battery powered. Theactuator for instance may be powered by the battery. The analytical unitmay also be powered by the battery.

In another embodiment the battery is a rechargeable battery.

In another embodiment the interior volume is hermetically sealed fromthe exterior surface when the shutter is in the closed position. Thismay have the benefit that when the shutter is in the closed position themedical instrument may be more readily cleaned.

In another embodiment, the interior volume is watertight when theshutter is in the closed position. It is understood that herein the termwatertight herein may in some cases apply to either water only, to someliquids, or to liquids in general.

In another embodiment, the interior volume is watertight from theexterior surface when the shutter is in the closed position.

In another embodiment, when the shutter is in the closed position theshutter and test port fit together so tightly that liquid is unable toenter the interior volume through the test port.

It is understood herein that the term “sealed” as used herein means thatwhen the shutter is in the closed position the shutter prevents thetransport of gas and/or liquid through the test port.

In another embodiment the first and second sealing surfaces may havedifferent properties. For example one could have a flexible surface suchas a gasket and one could be a rigid or hard surface. In another exampleboth surfaces may be similar, both may for example have a flexible orgasket-like surface.

In another embodiment the actuator is a manually operated lever, wheel,or crank.

In another embodiment the actuator may be a motor, stepper motor orother actuator, e.g. a stroke magnet.

In another embodiment the actuator comprises a motor. The medicalinstrument further comprises a memory for storing machine-executableinstructions. The medical instrument further comprises a processor forcontrolling the medical instrument. Execution of the machine-executableinstructions further causes the processor to control the motor toactuate the mechanism to move the shutter in the open position.Execution of the machine-executable instructions further cause theprocessor to analyze the test strip with the analytical unit to performthe measurement when the test strip is inserted into the test stripmount and the biological sample is placed on the test strip.

Execution of the machine-executable instructions further cause theprocessor to control the motor to actuate the mechanism to move theshutter in the closed position when the test strip is removed from thetest strip mount and the test strip port. In some examples the medicalinstrument may automatically detect when the test strip is removed andcontrols the motor automatically. In other examples there may be abutton or other user interface which the operator of the medicalinstrument uses to inform the processor that the test strip has beenremoved.

In another embodiment the shutter mechanism comprises a shutter shaftfixed to the shutter. The shutter shaft is configured for rotating aboutthe rotational axis. The rotational axis is parallel to the insertiondirection. The shutter is configured to rotate about the rotational axisin order to move between the open position and the closed position.

In another embodiment, the shutter mechanism comprises a shutter shaftthat is configured for rotating about a rotational axis. Moving theshutter between the closed position and the open position comprises arotation of the shutter about the rotational axis of the shutter shaft.The rotational axis is parallel to the insertion direction. The shutteris configured to rotate about the shutter shaft in order to move betweenthe open position and the closed position.

In another embodiment the shutter shaft has a fixed position along therotational axis. In this embodiment the actuator rotates the shuttershaft into position and the shutter shaft does not experience any lineartranslation along the rotational axis. This embodiment may have thebenefit that it is a simple mechanism with a minimal number of movingparts.

In another embodiment the shutter shaft is configured both forrotational and translational motion along the rotational axis. Theshutter further comprises an actuator shaft configured for rotationalmotion along a driving axis. The actuator shaft is rotationallyconnected to the actuator. The driving axis is parallel to therotational axis. The shutter mechanism is configured such that therotational motion of the driving axis causes rotational motion of theactuator shaft about the rotational axis. The shutter mechanism isfurther configured such that the rotational motion of the driving axiscauses translational motion of the actuator shaft along the rotationalaxis.

This embodiment may have the benefit that the combined rotational andlinear motion of the shutter enables for a shutter that may be openedand sealed a larger number of times. The shutter mechanism may beimplemented in a variety of different ways. For example the shuttershaft and the actuator shaft may be connected by a gear mechanism. Forexample the shutter shaft and the actuator shaft could be connected byscrew threads or other linear gear system that both rotates and movesthe shutter shaft. In other examples a system of cams could be used tocontrol the rotation and linear motion of the shutter shaft.

In the '567 application, as was described previously, the opening 42 isclosed by two shell like shutters 48. It is not disclosed how or if theyare sealed, but if they were it would be necessary to seal where thesurfaces of the housing 10 contact the shutters 48. This would be asliding contact that would wear any seal quickly and lead to failure.Additionally, the housing 10 and the shutters 48 would need to bemanufactured to tight dimensional tolerances in order for the shuttersto even seal. In contrast, the above mentioned embodiment may have theadvantage that the seal will last a larger number of times and can sealthe test strip port when manufactured to lower dimensional tolerances.

In another embodiment the driving axis is coaxial with the rotationalaxis. The shutter mechanism comprises a bearing sleeve for receiving theactuator shaft and the shutter shaft. The shutter mechanism comprises aguiding pin connected to the shutter shaft. The bearing sleeve isconnected to the housing. That is say the bearing sleeve is rigidly orpermanently connected to the housing. The bearing sleeve comprises aguideway for the guiding pin to control the rate of translational motionof the shutter shaft relative to the rotational motion of the shuttershaft. The guideway and the pin function essentially as a cam. As theactuator shaft is rotated this may cause the shutter shaft to rotatealso and the pin is then forced to move in the guideway. The pin thencontrols the linear position of the shutter shaft as the shutter isrotated. This may be used to quickly rotate the shutter into positionand then to force the shutter closed or open.

In another embodiment the actuator is a rotational motor.

In another embodiment the shutter shaft is configured for translationalmotion along the rotational axis. The shutter shaft further comprises anactuator shaft configured for translational motion along a driving axis.The actuator shaft is configured for translationally driving the shuttershaft along the rotational axis. The driving axis is parallel to therotational axis. The shutter mechanism is configured such that thetranslational motion of the driving axis causes rotational motion of theactuator shaft about the rotational axis. The shutter mechanism isfurther configured such that translational motion of the driving axiscauses translational motion of the actuator shaft along the rotationalaxis. In this embodiment the actuator shaft pushes the shutter shaftalong the rotational axis. The mechanism is configured such that thistranslational motion causes not just the translational motion of theshutter shaft but also rotational motion. This mechanism could beimplemented in a variety of ways. For example a spring or other elasticelement could be used to return the shutter shaft to an originalposition for example in the open position or in the closed position. Akeyway or cam or guideway could be used to control the rate oftranslational motion relative to the rotational motion.

In another embodiment the shutter mechanism further comprises an elasticelement for returning or forcing the shutter into the open position orinto the closed position.

In another embodiment the shutter mechanism further comprises a springconfigured for returning or forcing the shutter into the open positionor into the closed position.

In these embodiments the spring or elastic element could be configuredto apply a translational force which returns the shutter to either theopen or the closed position. When the actuator is no longer applyingforce, the spring or elastic element then moves the shutter back to itsoriginal position.

In an alternative, the spring or elastic element could be configured toapply a rotational force which is less than the rotational force appliedby the actuator. The actuator could be configured such that it applies aforce that overcomes the spring or elastic element and then moves theshutter into either the open or closed position. When the actuator is nolonger applying force, the spring or elastic element then moves theshutter back to its original position.

In these embodiments the spring or elastic element could be strongenough so that, for example, the actuator is moved into the openposition or into the closed position when the actuator is not in use.This may have several advantages. When the actuator is for example notpowered the shutter could be forced open or closed.

The use of a spring or elastic element may also provide for moreeffective sealing when the spring or elastic element forces or returnsthe shutter into the closed position. If the first and/or second sealingsurface are elastic their shape may permanently deform during thelifetime of the medical instrument. This may result in needing to closethe shutter more to maintain an effective seal. Using a spring orelastic element may be beneficial because the spring or elastic elementwould force the shutter to seal. An alternative would be to adjust theposition that the shutter is actuated to over a period of time. Howeverthis may be more complicated and/or require the attention of a servicetechnician than using a spring or elastic element.

In another embodiment the driving axis is coaxial with the rotationalaxis. The shutter mechanism comprises a bearing sleeve for receiving theactuator shaft and the shutter shaft. The shutter mechanism comprises aguiding pin connected to the shutter shaft. The bearing sleeve isconnected to the housing. The bearing sleeve comprises a guideway forguiding the pin to control the rate of rotational motion of the shuttershaft relative to translational motion of the shutter shaft.

In another embodiment the shutter mechanism comprises a spring orelastic element which restores the shutter to the open position or tothe closed position.

In another embodiment the actuator is a linear actuator or a linearmotor.

In another embodiment the medical instrument further comprises a userinterface for receiving user input that indicates that the medicalinstrument has been cleaned. Execution of the machine-executableinstructions further cause the processor to control the motor to actuatethe mechanism to move the shutter in the open position after receivingthe user input.

In another embodiment the medical instrument further comprises adetector for detecting if a test strip is inserted through the teststrip port. Execution of the machine-executable instructions furthercauses the processor to control the motor to place the shutter in theclosed position after the detector indicates that the test strip is notlonger inserted through the test strip port. For example once a teststrip is inserted into the test strip port whenever one is removed theshutter automatically closes. In some examples the detector fordetecting if the test strip is inserted could be an optical detector. Inother examples the detector may be a mechanical switch actuated if atest strip is inserted through the test strip port.

In another embodiment the first sealing surface is planar. The secondsealing surface is also planar.

In another embodiment the first sealing surface is convex. The secondsealing surface is concave.

In another embodiment the first sealing surface or the second sealingsurface is formed by an elastic gasket.

In another embodiment the analytical unit is an optical test stripanalyzer.

In another embodiment the analytical unit is an electrochemical teststrip analyzer.

In another embodiment the analytical unit is a combination of an opticaltest strip analyzer and an electrochemical test strip analyzer.

It is understood that one or more of the aforementioned embodiments ofthe invention may be combined as long as the combined embodiments arenot mutually exclusive.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following embodiments of the invention are explained in greaterdetail, by way of example only, making reference to the drawings inwhich:

FIG. 1 shows a perspective view of a shutter;

FIG. 2 shows an alternative perspective view of the shutter of FIG. 1;

FIG. 3 illustrates an example of a portion of a medical instrument in aperspective view;

FIG. 4 shows the illustration of FIG. 3 from a side view;

FIG. 5 shows a further perspective view of the portion of a medicalinstrument of FIG. 3;

FIG. 6 shows the illustration of FIG. 5 from a side view;

FIG. 7 illustrates a further example of a portion of a medicalinstrument in a perspective view;

FIG. 8 shows the illustration FIG. 7 from a side view;

FIG. 9 shows a further perspective view of the portion of a medicalinstrument of FIG. 7;

FIG. 10 shows the illustration of FIG. 9 from a side view;

FIG. 11 shows a further perspective view of the portion of a medicalinstrument of FIG. 7;

FIG. 12 shows the illustration of FIG. 11 from a side view;

FIG. 12A shows an alternative to the example shown in FIG. 12;

FIG. 13 illustrates a further example of a portion of a medicalinstrument;

FIG. 14 illustrates a further example of a portion of a medicalinstrument;

FIG. 15 illustrates an example of a medical instrument;

FIG. 16 illustrates a further example of a medical instrument; and

FIG. 17 shows a flow chart which illustrates an example of a method ofoperating the medical instrument of FIG. 15 or FIG. 16.

DETAILED DESCRIPTION

Like numbered elements in these figures are either equivalent elementsor perform the same function. Elements which have been discussedpreviously will not necessarily be discussed in later figures if thefunction is equivalent.

To measure the concentration of analytes in a body fluid, e.g. a glucoseconcentration from a small droplet of blood, disposable electrochemicalcapillary sensor test strips in combination with a meter to determinethe concentration are used. For receiving the sensor strip there is ahole in the shell of the meter, commonly referred to as “strip-port” ora “test strip port.”

In current medical instruments the strip-port is always open and thereis no possibility to close it. U.S. Pat. No. 8,158,081 B2 describes asolution to close the strip-port.

Because the strip-port of current medical instruments is always open,the inner part of the meter is not prevented from contamination fromoutside. Fluids, dust and anything else can come through the hole of thestrip-port to the interior of the meter. This can cause a technicalfault, up to uselessness of the meter.

In the professional use case it is e.g. required, that the completemeter get cleaned and disinfected after every test or every patient.Therefore also the strip-port has to be cleaned and disinfected. It islikely that a small amount of cleaning or disinfection agents camethrough the hole of the strip-port into the interior of the meter. Someof these agents are very aggressive and the risk that the meter getsdamaged is high.

Examples may have the feature of closing the strip-port every time it isnot used. This means, that the strip-port only is open when a strip isinserted in the meter. When the measurement is ready and the strip isremoved, the strip-port directly gets closed. The fastener or shutter isdesigned in the shape that the interior of the meter is prevented ofcontamination. Even when the strip-port get cleaned and disinfected,e.g. by whipping above the surface of the strip-port (e.g. withClorox-wipes), there is no risk of contamination and the meter isprevented from technical faults and damages.

It is beneficial to make sure that the meter can be cleaned anddisinfected very well. Therefore the surface of the meter and speciallythe area of the strip-port have to be as smooth as possible. To ensurethat, the complete mechanical system is an inner part of the meter andon the surface of the meter there are no notches or chamfers.

The fastener (shutter mechanism) has a planar part (a shutter) and onecylindrical part (a shutter shaft) orthogonally to the planar area onthe back side. The cylindrical part may be assembled in a bearing sleeve(or connector), in the way that it can rotate. The front side of theplanar part may be a first sealing surface with a gasket (or elasticgasket). In the planar area (shutter) of the fastener there may be ahole as an opening for the sensor strip (test strip opening). Thehousing of the meter contains also a hole for the strip.

When the strip-port is closed, the hole of the planar area of thefastener is located inside of the meter (interior volume) and the gaskethas contact with the housing. The housing, gasket, and planar part forma seal. Therefore, the inner part is protected from contamination.

To open the strip-port, the fastener rotates around its cylindrical partin the way that the hole is located in front of the opening of thehousing. Now it is possible to insert the strip.

FIGS. 1 and 2 show two different perspective views of the same shutter100. The shutter can be seen as having a first sealing surface 102 thatis formed by a gasket 104. There is a hole in the shutter 100 labeled106 that is the test strip opening 106.

In this example the test strip opening is a hole through the shutter100. However, the test strip opening 106 could also be formed by an edgeof the shutter 100. That is to say the entire material in the vicinityof the test strip opening 106 could be removed instead. The shutter 100is shown as being attached to a shutter shaft 108. The shutter shaft 108has a rotational axis 110. The shutter mechanism shown in the followingdrawings illustrates how the shutter shaft 108 rotates about the axis110 and causes the shutter 100 to move between the open and the closedposition.

FIG. 3 shows a perspective view of a portion of the medical instrument300. FIG. 4 shows the side view of the same view that is shown in FIG.3. The portion of the medical instrument 300 has a housing 302 that hasan exterior surface 304 and an interior surface 306. The housing 302surrounds an interior volume 308 that is bounded by the interior surface306. Between the exterior surface 304 and the interior surface 306 thereis a test strip port 312. A test strip 310 can be shown as beinginserted along insertion direction 328 through the test strip port 312.In FIGS. 3 and 4 the shutter 100 is shown in the open position. Theshutter shaft 108 is shown as being connected to an actuator shaft 330via a coupling 332. In the examples shown in FIGS. 3 and 4 the distanceof the shutter shaft along the rotational axis 110 is fixed.

FIGS. 5 and 6 show the same portion of the medical instrument 300 thatwas shown in FIGS. 3 and 4. In FIGS. 5 and 6 the shutter 100 is shown inthe closed position. In the example shown in FIGS. 5 and 6 the actuatorshaft 330 has been rotated. This caused the coupling 332 and the shuttershaft 108 to also rotate about the rotational axis 110. The test stripopening 106 has been rotated away from the test strip port 312 andinstead the gasket 104 has been rotated into place such that the firstsealing surface 102 comes in contact with the second sealing surface320. The interior volume 308 is now sealed from the exterior surface304. The medical instrument can for example now be cleaned with a liquidcleaning solvent or solution.

Another solution is that the movement of the cylindrical part is notonly a rotational movement. The movement is divided into two sequences:A rotating and a linear sequence. The two sequences are realized with alink motion system or a linkage.

In the cylindrical part of the fastener is a hole for a pin. In thebearing sleeve there is guideway for the pin of the fastener.

The link motion is designed in the way, that there is a gap betweengasket and housing in the opened position of the strip-port. When thestrip-port is closed, the fastener (shutter) at first rotates (orprimarily rotates with a smaller linear movement) and then makes thelinear movement (or primarily a linear movement with a smallerrotational movement) with the linear movement the gap between housingand gasket get closed and the sealing is tight. By opening thestrip-port the opposite occurs, at first the linear movement occurs andthen the fastener rotates.

The advantage of this situation may be that there no friction (or atleast reduced friction), because of the rotation, between the gasket andhousing anymore.

FIGS. 7, 8, 9, 10, 11 and 12 illustrate a further example of a portionof a medical instrument 700. FIGS. 7 and 8 show the shutter 100 in theopen position. FIG. 7 is a perspective view and FIG. 8 is a side view ofthe perspective shown in FIG. 7. FIG. 9 shows the shutter 100 in anintermediate position between being open and closed. FIG. 9 is aperspective view and FIG. 10 is a side view of the perspective shown inFIG. 9. FIGS. 11 and 12 show the shutter 100 in the closed position.FIG. 11 shows a perspective view. FIG. 12 shows the side view of theperspective shown in FIG. 11.

In FIGS. 7 and 8 the test strip opening 106 is shown as being alignedwith the test strip port 312 such that a test strip can be insertedalong the insertion direction 328. The mechanism in FIGS. 7-12 issimilar to that shown in FIGS. 1-4 except the coupling 332 has beenreplaced with a bearing sleeve 702. The bearing sleeve 702 is rigidlyconnected to the housing 302. During the actuation of the mechanism thebearing sleeve 702 does not move. There is a guiding pin 704 which isconnected rigidly to the shutter shaft 108. The bearing sleeve 702 has aguideway 706 which receives the guiding pin 704. The actuator shaft 330is connected to the shutter shaft 108 so that when the actuator shaft330 make a translational movement along the rotational axis 110 theshutter shaft 108 rotates. The guideway 706 defines the rotationalposition of the shutter shaft 108 relative to the translational positionof the shutter shaft 108.

For example, a rod or other driveshaft could be connected to a hole orcross-section in both the shutter shaft 108 and the actuator shaft 330such that the shutter shaft 108 turns with the actuator shaft 330 but isfree to move along the rotational axis 110. The combination of theguiding pin 704 and the guideway 706 controls the position of theshutter 100 along the rotational axis 110 as a function of thetranslational position of the shutter 110. This may be useful becausethe motion of the shutter as it is rotated into place along therotational axis 110 can be controlled. For example in the example shownin FIGS. 1-4 the gasket 104 is always in contact with the interiorsurface 306. In the example shown in FIGS. 7-12 the gasket in the openposition 104 does not contact the interior surface 306. This for examplemay result in reduced wear and tear on the gasket 104.

In FIGS. 9 and 10 it can be seen that the actuator shaft 330 has beenmoved along the rotational axis. This has also caused the shutter shaft108 to rotate. The test strip opening 106 has been rotated away from thetest strip port 312. The gasket 104 is now in position for sealing thetest strip port 312. However, at this point it can be seen that thefirst sealing surface 102 is not yet in contact with the second sealingsurface 320. The guideway 706 can be seen as sloping sharply towards thedirection of the rotational axis 110. This shows that as the actuatorshaft 330 is further moved forward the motion of the shutter 100 will bepredominantly in a direction of the axis 110 causing the first 102 andsecond 320 sealing surfaces to contact thereby sealing the test stripport 312.

FIGS. 11 and 12 show the shutter after it has been moved into the closedposition. It can be seen that the first 102 and second 320 sealingsurfaces are now in contact and that the test strip port 312 is nowsealed.

FIG. 12A shows an alternative design for the guideway (706) of FIG. 12.In the example of 12A a rotational movement is used instead of atranslational motion to actuate the shutter. A rotation of the shuttershaft 330 causes a translational movement (combined with a shortrotation) of the shutter. In such an example the guideway may have afirst section 1200 and a second section 1202 whereby the second section1202 is closer to the first sealing surface 102 of the shutter than thefirst section 1200. Both the first 1200 and second section 1202, theguideway 706 is offset from the rotational axis 110. The guidewaydefines a path 1204 that the guiding pin 704 follows. When the path isprojected onto the rotational axis 110, the angle of a small segment ofthe path 1204 relative to the rotational axis 110 is larger in the firstsection 1200 than in the second section 1202. This causes a morerotational movement if the pin is moved in the first section 1200 of theguideway and a more translational movement if the pin is move in thesecond section 1202 of the guideway.

In another example, the angle of the path 1204 relative to therotational axis 110 in the first section 1200 is between 15° and 75°. Inanother examples the angle of the path 1204 relative to the rotationalaxis 110 in the first section 1200 is between 30° and 60°. In anotherexamples the angle of the path 1204 relative to the rotational axis 110in the first section 1200 is about 45°.

In another examples the angle of the path 1204 relative to therotational axis 110 in the second section 1202 is between 0, 1° and 30°.In another example the angle of the path 1204 relative to the rotationalaxis 110 in the second section 1202 is between 0, 1° and 15°. In anotherexample the angle of the path 1204 relative to the rotational axis 110in the second section 1202 is between 0, 1° and 5°.

FIG. 13 shows a further example of a portion of a medical instrument1300. In this example the actuator is a linear actuator 1302 or a liftmagnet. This causes the actuator shaft 330 to exert a force and pull theshutter shaft 108 towards the linear actuator 1302. As the shutter shaft108 is pulled a bearing sleeve 702 and a guiding pin, which is not shownin this Fig., cause the shutter 100 also to rotate and move into theopen position. When the linear actuator 1302 ceases to exert a force onthe actuator shaft 330 and the shutter shaft 108 then a spring 1306 orother elastic element force the shutter shaft 108 towards the interiorsurface 306 and the bearing sleeve 702 causes the shutter 100 to rotateand move back into the closed position. The example shown in FIG. 13will automatically close when a force is no longer exerted by the linearactuator 1302. FIG. 13 shows an analytical unit 1304 which a test stripcan be inserted into.

FIG. 14 shows a further example of a portion of a medical instrument1400. The example shown in FIG. 14 is similar to that shown in FIG. 13except in this example the actuator is a rotational actuator 1402 or arotational motor. For example it could be stepper motor. The tip of theactuator shaft 330 in this example is threaded and mates with a threadedportion 1404 of the shutter shaft 108. As the actuator shaft 330 rotatesthe threads exert force on the shutter shaft 108 and the bearing sleeve702 also causes the shutter 100 to rotate closed or open depending onwhether the motor 1402 is going in one direction or the other.

FIG. 15 shows an example of a medical instrument 1500 that incorporatesthe portion of the medical instrument 300 shown in FIGS. 1-14. Themedical instrument has a housing 302 which has an exterior surface 304and an interior surface 306. The interior surface 306 surrounds aninterior volume 308. There is a test strip port 312 that is shown asbeing sealed by a shutter mechanism. The medical instrument could bealtered to use the shutter mechanism according to any one of themechanisms shown in FIGS. 1-14. Shown is a motor 1402 which has anactuator is used to drive shutter shaft 108. The motor 1402 can be usedto automatically open or close the shutter 100. In this Fig. the shutteris shown as being closed and the test strip port 312 is sealed. When thetest strip port 312 is open a test strip can be inserted into ananalytical unit 1508. Inside the analytical unit 1508 there is a teststrip mount 1510 which is configured for receive the test strip toperform a measurement.

Adjacent to the analytical unit 1508 and the shutter 100 is a stripdetector 1520. The strip detector 1520 is a sensor (e.g. mechanical,optical, capacitive) which is used to detect the presence of a teststrip within the medical instrument 1500. The medical instrument 1500 isfurther shown as containing a processor 1515. The processor 1515 isconnected to the motor 1402, the analytical unit 1508, the optionalstrip detector 1520 and also a touch screen display 1514. The processor1515 is further connected to a memory 1511. The processor 1515 isconfigured so that it can send and receive instructions for thesecomponents and control the operation and function of the medicalinstrument 1500. The memory 1511 is shown as containing a set ofinstructions 1512. Execution of the instructions 1512 enables theprocessor 1515 to control and operate the medical instrument 1500. Thememory 1511 is further shown as containing at least one measurement 1513that was acquired using the analytical unit 1508.

The touch screen 1514 is configured for displaying data and informationas well as receiving input from an operator or user of the medicalinstrument 1500. For example when the medical instrument 1500 has itstest strip port sealed as is shown in FIG. 15; it may display a message1516 which asks if the cleaning protocol has been finished. The messagecould for example be “Finished with cleaning protocols?” There is agraphical user interface control element 1518 or button which theoperator can use to inform the processor 1515 that a cleaning protocolhas been finished. The control element 2518 could example have the text“Yes” displayed on it. For example when the cleaning protocol isfinished, the processor 1515 may control the motor 1402 such that theshutter 100 is opened and it is then possible to insert a test stripinto the analytical unit and mount it properly within the test stripmount 1510 so that a further measurement 1513 can be performed.

FIG. 16 shows a further example of a medical instrument 1600. Themedical instrument 1600 is similar to the medical instrument 1500 shownin FIG. 15. In this example there is a gearbox 1602 which is used toconnect the shutter shaft 108 and the actuator shaft 1330. The steppermotor 1402 in this example is located off axis so that it has a separatedriving axis 1604 that is parallel but is not coaxial with therotational axis 110. The gearbox 1602 could be constructed in differentways. In one example it could simply rotate the shutter 100 as was shownin FIG. 15. In other examples the gearbox 1602 could also incorporate atranslational motion so that the shutter 100 first moves into positionand then closes.

FIG. 17 shows a flowchart which shows one method of operating themedical instrument 1500 of FIG. 15 or the medical instrument 1600 ofFIG. 16. First in step 1700 the actuator motor 1402 is controlled tomove the shutter 100 into the open position. In FIGS. 15 and 16 theactuator 1402 is shown as being a motor 1402. In other examples theactuator for instance may be controlled or moved manually. Next in step1702 a biological sample is placed onto a test strip.

Next in step 1704 a test strip is inserted into the test strip port 312such that the test strip passes through the test strip support and intothe test strip mount 1510. Next in step 1706 the test strip is analyzedwith the analytical unit 1508 to perform the measurement 1513. Next instep 1708 the test strip is removed from the medical instrument 1500,1600. Next in step 1710 the actuator 1402 is controlled to actuate themechanism 1501 to move the shutter 100 into the closed position.

Finally in step 1712 the exterior surface 304 of the medical instrument1500, 1600 is cleaned. The protocol for cleaning and disinfection themedical instrument 1500, 1600 may be performed with chemicals whicheasily damage the electronics and other components of the medicalinstrument 1500, 1600. For example in a clinical setting the medicalinstrument 1500, 1600 will likely be cleaned after every use or at leastbetween use between different patients. The cleaning protocol mayinvolve several steps. For example the protocol may begin with themedical instrument being wiped down to remove any obvious fluids orcontaminants on the surface. Then, one or more steps where the medicalinstrument 1500, 1600 may be cleaned and/or disinfected with one or morechemical solutions may be performed. Finally, the medical instrument1500, 1600 may be dried. Once the cleaning and disinfection protocol hasbeen finished then the operator or user may elect to open the shutter100 in preparation for inserting another test strip.

LIST OF REFERENCE NUMERALS

-   -   100 shutter    -   102 first sealing surface    -   104 gasket    -   106 test strip opening    -   108 shutter shaft    -   110 rotational axis    -   300 portion of medical instrument    -   302 housing    -   304 exterior surface    -   306 interior surface    -   308 interior volume    -   310 test strip    -   312 test strip port    -   320 second sealing surface    -   328 insertion direction    -   330 actuator shaft    -   332 coupling    -   700 portion of medical instrument    -   702 bearing sleeve    -   704 guiding pin    -   706 guideway    -   1200 first section    -   1202 second section    -   1204 path    -   1300 portion of medical instrument    -   1302 linear actuator or lift magnet    -   1304 analytical unit    -   1306 spring or elastic element    -   1400 portion of medical instrument    -   1402 rotational actuator    -   1404 threaded portion    -   1500 medical instrument    -   1502 mechanism portion    -   1504 motor    -   1506 actuator    -   1508 analytical unit    -   1510 test strip mount    -   1511 memory    -   1512 instructions    -   1513 measurement    -   1514 touch screen    -   1515 processor    -   1516 message “finished with cleaning protocols?”    -   1518 graphical user interface control element    -   1520 strip detector    -   1600 medical instrument    -   1602 gearbox    -   1604 driving axis    -   1700 control the actuator to actuate the mechanism to move the        shutter in the open position    -   1702 place the biological sample on the test strip    -   1704 insert a test strip into the test strip port such that the        test strip passes through the test strip support and into the        test strip mount    -   1706 analyze the test strip with the analytical unit to perform        the measurement    -   1708 remove the test strip from the medical instrument    -   1710 control the actuator to actuate the mechanism to move the        shutter in the closed position; and    -   1712 clean the exterior surface of the medical instrument.

The invention claimed is:
 1. A method of operating a medical instrument,wherein the medical instrument is an analyzer for performing ameasurement on a biological sample using a test strip, wherein themedical instrument comprises: a housing with an exterior surface,wherein the housing comprises an interior surface surrounding aninterior volume; an analytical unit for analyzing the test strip,wherein the analytical unit is within the interior volume, wherein theanalytical unit comprises a test strip mount configured for receivingthe test strip to perform the measurement; a test strip port between theexterior surface and the interior surface, wherein the test strip portis configured for receiving the test strip, wherein the test strip portis aligned with the test strip mount along an insertion direction; ashutter for sealing the test strip port, wherein the shutter isconfigured for being in an open position and a closed position, whereinthe shutter is within the interior volume, wherein the shutter isconfigured for sealing the test strip port when in the closed position,wherein the shutter comprises a test strip opening, wherein the teststrip opening is aligned with the test strip port and the test stripmount when the shutter is in the open position, wherein the shutter hasa first sealing surface, wherein the test strip port has a secondsealing surface, wherein the first sealing surface and the secondsealing surface are configured to mate in the closed position, whereinthe shutter comprises a shutter mechanism for moving the shutter betweenthe open position and the closed position, wherein moving the shutterbetween the closed position and the open position comprises a rotationof the shutter parallel to the insertion direction, wherein the shuttermechanism comprises a shutter shaft fixed to the shutter, wherein theshutter shaft is configured for rotating about a rotational axis,wherein the rotational axis is parallel to the insertion direction,wherein the shutter is configured to rotate about the rotational axis tomove between the open position and the closed position; and an actuatorfor actuating the mechanism to move the shutter between the openposition and the closed position; wherein the method comprises the stepsof: controlling the actuator to actuate the mechanism to move theshutter in the open position; placing the biological sample on the teststrip; inserting the test strip into the test strip port such that thetest strip passes through the test strip opening and into the test stripmount; analyzing the test strip with the analytical unit to perform themeasurement; removing the test strip from the medical instrument;controlling the actuator to actuate the mechanism to move the shutter inthe closed position; and cleaning the exterior surface of the medicalinstrument.
 2. A medical instrument, wherein the medical instrument isan analyzer for performing a measurement on a biological sample using atest strip, wherein the medical instrument comprises: a housing with anexterior surface, wherein the housing comprises an interior surfacesurrounding an interior volume; an analytical unit for analyzing thetest strip, wherein the analytical unit is within the interior volume,wherein the analytical unit comprises a test strip mount configured forreceiving the test strip to perform the measurement; a test strip portbetween the exterior surface and the interior surface, wherein the teststrip port is configured for receiving the test strip, wherein the teststrip port is aligned with the test strip mount along an insertiondirection; a shutter for sealing the test strip port, wherein theshutter is configured for being in an open position and a closedposition, wherein the shutter is within the interior volume, wherein theshutter is configured for sealing the test strip port when in the closedposition, wherein the shutter comprises a test strip opening, whereinthe test strip opening is aligned with the test strip port and the teststrip mount when the shutter is in the open position, wherein theshutter has a first sealing surface, wherein the test strip port has asecond sealing surface, wherein the first sealing surface and the secondsealing surface are configured to mate in the closed position, whereinthe shutter comprises a shutter mechanism for moving the shutter betweenthe open position and the closed position, wherein moving the shutterbetween the closed position and the open position comprises a rotationof the shutter parallel to the insertion direction, wherein the shuttermechanism comprises a shutter shaft fixed to the shutter, wherein theshutter shaft is configured for rotating about a rotational axis,wherein the rotational axis is parallel to the insertion direction,wherein the shutter is configured to rotate about the rotational axis tomove between the open position and the closed position; and an actuatorfor actuating the mechanism to move the shutter between the openposition and the closed position.
 3. The medical instrument of claim 2,wherein the shutter shaft has a fixed position along the rotationalaxis.
 4. The medical instrument of claim 2, the shutter shaft isconfigured for translational motion along the rotational axis, whereinthe shutter further comprises an actuator shaft configured forrotational motion along a driving axis, wherein the actuator shaft isrotationally connected to the actuator, wherein the driving axis isparallel to the rotational axis, wherein the shutter mechanism isconfigured such that rotational motion of the driving axis causesrotational motion of the actuator shaft about the rotational axis,wherein the shutter mechanism is further configured such that rotationalmotion of the driving axis causes translational motion of the actuatorshaft along the rotational axis.
 5. The medical instrument of claim 4,wherein the driving axis is coaxial with the rotational axis, whereinthe shutter mechanism comprises a bearing sleeve for receiving theactuator shaft and the shutter shaft, wherein the shutter mechanismcomprises a guiding pin connected to the shutter shaft, wherein thebearing sleeve is connected to the housing, wherein the bearing sleevecomprises a guideway for guiding the guiding pin to control the rate oftranslational motion of the shutter shaft relative to the rotationalmotion of the shutter shaft.
 6. The medical instrument of claim 3,wherein the shutter mechanism further comprises an elastic element forreturning the shutter into the open position or into the closedposition.
 7. The medical instrument of claim 2, wherein the actuator isa rotational motor.
 8. The medical instrument of claim 2, wherein theshutter shaft is configured for translational motion along therotational axis, wherein the shutter further comprises an actuator shaftconfigured for translational motion along a driving axis, wherein theactuator shaft is configured for translationally driving the shuttershaft along the rotational axis, wherein the driving axis is parallel tothe rotational axis, wherein the shutter mechanism is configured suchthat translational motion of the driving axis causes rotational motionof the actuator shaft about the rotational axis, wherein the shuttermechanism is further configured such that translational motion of thedriving axis causes rotational motion of the actuator shaft along therotational axis.
 9. The medical instrument of claim 8, wherein thedriving axis is coaxial with the rotational axis, wherein the shuttermechanism comprises a bearing sleeve for receiving the actuator shaftand the shutter shaft, wherein the shutter mechanism comprises a guidingpin connected to the shutter shaft, wherein the bearing sleeve isconnected to the housing, wherein the bearing sleeve comprises aguideway for guiding the guiding pin to control the rate of rotationalmotion of the shutter shaft relative to translational motion of theshutter shaft.
 10. The medical instrument of claim 2, wherein theactuator is a linear actuator.
 11. The medical instrument of claim 2,wherein the first sealing surface is formed from a gasket.
 12. Themedical instrument of claim 2, wherein the analytical unit is any one ofthe following: an optical test strip analyzer, an electrochemical teststrip analyzer, and combinations thereof.
 13. The medical instrument ofclaim 2, wherein the actuator comprises a motor, wherein the medicalinstrument further comprises a memory for storing machine executableinstructions, wherein the medical instrument further comprises aprocessor for controlling the medical instrument, wherein execution ofthe machine executable instructions causes the processor to: control themotor to actuate the shutter mechanism to move the shutter in the openposition; analyze the test strip with the analytical unit to perform themeasurement when the test strip is inserted into the test strip mountand the biological sample is placed on the test strip; and control themotor to actuate the shutter mechanism to move the shutter in the closedposition when the test strip is removed from the test strip mount andthe test strip port.
 14. The medical instrument of claim 13, wherein themedical instrument further comprises a user interface for receiving userinput that indicates that the medical instrument has been cleaned,wherein execution of the machine executable instructions further causethe processor to control the motor to actuate the mechanism to move theshutter in the open position after receiving the user input.
 15. Themedical instrument of claim 2, wherein the second sealing surface iswithin the interior volume.
 16. The medical instrument of claim 2,wherein the 30 second sealing surface is on the on the interior surface.17. The medical instrument of claim 2, wherein in the open position thefirst sealing surface is within the interior volume.
 18. The medicalinstrument of claim 2, wherein the first sealing surface and the secondsealing surface form the seal within the interior volume when theshutter is in the dosed position.
 19. The medical instrument of claim 2,wherein the test strip port is an opening in the housing.
 20. Themedical instrument of claim 19, wherein the test strip port contacts theinterior surface and the exterior surface.